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Clinical Trial NCT07388888 (Ca(OH)2 - CNPs) for Pulp Necrosis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Antibacterial Effect of Two Different Intracanal Medicaments and Their Effect on Post-operative Pain (Ca(OH)2 - CNPs) Phase 4 52

Not yet recruiting
Clinical Trial NCT07388888 (Ca(OH)2 - CNPs) is designed to study Treatment for Pulp Necrosis. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 February 2026 until the study accrues 52 participants. Led by Ain Shams University, this study is expected to complete by 1 April 2027. The latest data from ClinicalTrials.gov was last updated on 5 February 2026.
Brief Summary
Evaluation of antibacterial effect of two different intracanal medicaments on bacterial load in infected mature permanent teeth and their effect on post-operative pain level.
Detailed Description
Microorganisms within the root canal system exist as complex, multispecies biofilms made up of microcolonies that adhere permanently to each other and to surfaces such as dentin. The characteristics of these biofilms-including their composition, thickness, and location-vary according to environmental conditions like nutrient availability, pH, oxygen levels, and exposure to the oral cavity. Endodontic treatment aims t...Show More
Official Title

Comparative Evaluation of Anti-Bacterial Efficacy Of Two Different Intracanal-Medicaments and Their Effect On Post-Operative Pain Level (A Randomized Clinical Trial)

Conditions
Pulp Necrosis
Other Study IDs
  • Ca(OH)2 - CNPs
  • FDASU-Rec IM012482
NCT ID Number
NCT07388888
Start Date (Actual)
2026-02
Last Update Posted
2026-02-05
Completion Date (Estimated)
2027-04
Enrollment (Estimated)
52
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
effect of two intracanal medicaments on bacterial load and post operative pain level in mature teeth with necrotic pulp
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparatorcalcium hydroxide (Ca(OH)2)
intracanal medicament in infected root canal
Calcium Hydroxide (Ca(OH)2)
Non setting calcium hydroxide intracanal medicament is injected through the root canal for two weeks
ExperimentalChitosan nano particles (CNPs)
intracanal medication in infected root canal
chitosan nanoparticles gel
Nano chitosan gel is injected through the root canal as an intracanal medicament for two weeks
No Interventioncontrol
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Bacterial load.
Samples will be collected from the infected root canal before and after injection of intracanal medicaments then bacterial colonies will be counted for colony forming units per milliliter (CFU/ml) to assess the effect of the intracanal medicaments used.
two weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Visual Analogue Scale (VAS) to measure post operative pain level.
the patient is given a 10 cm sheet to mark their pain level where (0) represents no pain and (10) the worst pain.
12 hours, 24 hours, 48 hours, 72 hours.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • free medical history,
  • mature infected permanent single rooted teeth diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization and restoration.

  • Patients who are not included in the age range of the study or having a systemic condition.
  • Teeth with severe fractures or resorption or periodontally compromised.
Ain Shams University logoAin Shams University
Study Responsible Party
Rana mohamed mustafa nagdy, Principal Investigator, Dentist, Ain Shams University
Study Central Contact
Contact: Rana M Nagdy, MSc, +201006224327, [email protected]
1 Study Locations in 1 Countries
Faculty of Dentistry Ain Shams University, Cairo, Egypt